5 benign urology headlines you missed in Q2 2026

The second quarter of 2026 saw continued momentum across benign urology, with important regulatory developments, emerging clinical evidence, and advances in medical technology shaping the field. From proposed updates to testosterone replacement therapy labeling to the approval of the first oral carbapenem for complicated urinary tract infections, these headlines have the potential to influence clinical practice and future research.

Take a look below at 5 stories from Q2 that are worth catching up on.

HHS requests testosterone therapy label updates, citing new safety data

The US Department of Health and Human Services has requested labeling updates for testosterone replacement therapy products, proposing removal of the longstanding limitation of use for age-related hypogonadism and revisions to prostate cancer and benign prostatic hyperplasia (BPH) warnings based on newer evidence.¹ The proposed changes would limit the prostate cancer contraindication to men with metastatic disease, maintain recommendations for prostate screening and monitoring, and revise BPH warnings to reflect evidence showing no worsening of lower urinary tract symptoms in men with mild to moderate BPH receiving testosterone therapy.

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FDA approves tebipenem pivoxil for complicated urinary tract infections

In June 2026, the FDA approved tebipenem pivoxil (Utebzi) for complicated urinary tract infections (cUTI), including pyelonephritis, caused by several susceptible microorganisms in adult patients who have limited or no alternative oral treatment options.² The approval is supported by results from the phase 3 PIVOT-PO trial (NCT06059846), which met its primary end point by showing that tebipenem pivoxil was noninferior to imipenem-cilastatin in regard to the overall response rate (composite of clinical cure plus microbiological eradication) at the test-of-cure visit in hospitalized adult patients with cUTI.

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Break Wave lithotripsy meets both co-primary end points in SOUND trial

Data from the SOUND trial were presented at the 2026 American Urological Association Annual Meeting in Washington DC, showing that Break Wave ultrasonic lithotripsy is noninferior to extracorporeal shock wave lithotripsy for safety and efficacy.³ Results from the SOUND trial supported FDA 510(k) clearance of the Break Wave device in January 2026.

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FDA clears Glean Abdominal Sensor, expanding catheter-free urodynamics platform

In May 2026, the FDA granted 510(k) clearance to the Glean Abdominal Sensor, expanding the Glean Urodynamics System to enable multi-channel urodynamic testing in a wireless, catheter-free ambulatory format.⁴ The clearance broadens the system’s capability to capture abdominal and detrusor pressure alongside cystometry and pressure flow measurements without catheter interference.

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Trial launches of Edison Histotripsy System for benign prostatic hyperplasia

In April 2026, HistoSonics announced that the first patients had been treated in the WOLVERINE study (NCT07214675), evaluating the Edison Histotripsy System for the management of symptomatic BPH.⁵ Patients in the study will undergo the histotripsy procedure, which includes “a non-thermal, mechanical process of focused ultrasound” to induce “mechanical destruction of prostate tissue.” Final completion of the study is expected in October 2027.

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REFERENCES

1. HHS announces requested updates to testosterone therapy product labels. News release. US Department of Health and Human Services. June 18, 2026. Accessed June 30, 2026. https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html

2. FDA approves first oral carbapenem therapy for complicated urinary tract infections. News release. US Food & Drug Administration. June 17, 2026. Accessed June 30, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-carbapenem-therapy-complicated-urinary-tract-infections

3. Chew BH, Harper JD, Ahn J, et al. SOUND pivotal trial of Break Wave lithotripsy for upper urinary tract stones. Presented at: 2026 American Urological Association Annual Meeting; May 15-18, 2026; Washington, DC. https://www.auajournals.org/doi/10.1097/01.JU.0001192572.07890.f8.03

4. Bright Uro receives FDA clearance For Glean® abdominal sensor. News release. Bright Uro. May 7, 2026. Accessed June 30, 2026. https://www.prnewswire.com/news-releases/bright-uro-receives-fda-clearance-for-glean-abdominal-sensor-302765627.html

5. HistoSonics treats first patients evaluating the Edison® Histotripsy System for the treatment of benign prostatic hyperplasia (BPH). News release. HistoSonics. March 30, 2026. Accessed June 30, 2026. https://www.businesswire.com/news/home/20260330349844/en/HistoSonics-Treats-First-Patients-Evaluating-the-Edison-Histotripsy-System-for-the-Treatment-of-Benign-Prostatic-Hyperplasia-BPH